Viagra for the Treatment of IUGR - Tabular View

Tracking Information

First Received Date ^ICMJE

July 3, 2006

Last Updated Date

July 3, 2006

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Uteroplacental perfusion
Fetal growth
Maternal and fetal safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Viagra for the Treatment of IUGR

Official Title ^ICMJE

Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy

Brief Summary

It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels’ ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.

Detailed Description

Each participant will receive, after informed consent a 25 mg tablet of Viagra [sildenafil citrate ]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

IUGR

Intervention ^ICMJE

Drug: Viagra administration in IUGR/PET pregnancies

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

IUGR/PET/Pregnancy weeks 24-33.
Informed consent.

Exclusion Criteria:

Maternal cardiovascular morbidity.
Usage of any vasodilator medication
Smoking
Diabetes

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Zeev Blumenfeld, MD

972-4-8542577

z_blumenfeld@rambam.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00347867

Responsible Party

Study ID Numbers ^ICMJE

Viagra.CTIL

Study Sponsor ^ICMJE

Rambam Health Care Campus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Zeev Blumenfeld, MD

RAMBAM Health Care Campus, Technion

Information Provided By

Rambam Health Care Campus

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP